Densert 1997.
| Methods |
Allocation: randomised, multicentre, placebo‐controlled trial with immediate follow‐up Design: placebo‐controlled study |
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| Participants |
Number: n = 39 Age/gender: age 20 to 65 years old; sex distribution not described Setting: Department of Otolaryngology, University of Lund, Lund, Sweden and University Hospital, Linkoping, Sweden Eligibility criteria: duration of clinical symptoms of definite Ménière's disease according to the 1995 Committee criteria, such as cochlear hearing loss, aural pressure and recurrent spells of vertigo or dizziness within 6 weeks before the test, hearing loss within the range of 20 dB to 65 dB pure‐tone average, 7 or more on the Gibson's 10‐point Ménière's scale, ECoG recordings showing a SP/AP ratio of > 33%, age 20 to 65 years, a patent ventilation tube in the tympanic membrane Exclusion criteria: vestibular Ménière's disease, significant systemic disease requiring medication with steroids, or those receiving diuretics or vasodilators 2 weeks before the test and previous local overpressure treatment Baseline characteristics: only pre‐ventilation tube values for ECoG measurements. In the active group: SP/AP (%) in 48.1 (11.6), W(ms) 2.8 (0.65) and for the placebo group: SP/AP (%) 44.6 99.6) and W(ms) 2.4 (0.7) |
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| Interventions |
Intervention group: portable air pressure generator Comparator group: placebo Use of additional interventions: none |
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| Outcomes |
Primary outcome: ECoG measurements Secondary outcomes: VAS scores for vertigo, tinnitus, aural fullness |
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| Notes | No use of Meniett device, but comparable air pressure generator | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | High risk | Open study; no baseline characteristics of the included patients were given concerning vertigo, tinnitus or aural fullness |
| Allocation concealment (selection bias) | Unclear risk | No description of allocation concealment |
| Blinding (performance bias and detection bias) All outcomes | Unclear risk | No description of blinding |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Unclear whether there are drop‐outs or exclusions; no report or description of excluded patients |
| Selective reporting (reporting bias) | High risk | No exact data or statistical analysis given. Quote: "The results from the visual scales evaluating changes in the subjective symptoms on vertigo, tinnitus and aural fullness showed no significant changes in either the active or the placebo group" |
| Other bias | High risk | Overall lack of adequate description of the included patients, baseline characteristics and statistical data including lack of explanation of measurements in tables and figures |
| Grading: AAO‐HNS diagnosis | Low risk | Grade 1 |
| Grading: AAO‐HNS outcome measurement | High risk | The AAO‐HNS criteria for 'control of vertigo' are not used. There are no data on the frequency of vertigo. Additionally, there are no descriptions of the visual analogue scales used and no statistical presentations of the baseline characteristics or measurements after the experiment except for the ECoG measurements. The measurements are not according to the AAO‐HNS criteria |